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NCT Number: NCT05148039

Comprehensive Assessment of Nutrition and Dietary Intervention in Hypermobile Ehlers Danlos Syndrome

This study involves a comprehensive nutritional assessment of hEDS participants who have functional gastrointestinal disorders and dietary intervention to broaden their food choices and nutritional intake.

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Key information

Conditions

Hypermobile Ehlers-Danlos Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Ehlers-Danlos syndrome type 3 Functional Gastrointestinal Disorders Gastrointestinal Diseases Intestinal Diseases Irritable Bowel Syndrome

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queen Marys University London

London, United Kingdom

About this study

The impact of diet on symptoms in patients with Hypermobile Ehlers Danlos Syndrome (hEDS/HSD) is widely recognised yet poorly understood. The investigators aim is to assess existing dietary patterns and nutritional status in hEDS/HSD as well as pilot a personalised dietary strategy to optimise nutrition. Participants recruited from EDS UK and a tertiary Neurogastroenterology clinic at the Royal London Hospital will undergo comprehensive nutritional assessment and blood tests. The investigators will then undertake a feasibility study of personalised dietary intervention in select cohort of patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Have completed Phase I of the CANDI-hEDS study
  • Diagnosis of hEDS / HSD according to physical examination and history taking
  • Diagnosis of Functional Dyspepsia and / or Irritable Bowel Syndrome according to Rome IV criteria
  • Able and willing to give informed consent
  • Access to video conferencing and a smart phone device
  • Able to travel to the Wingate Institute

Exclusion criteria

  • Dependent upon artificial feeding (parenteral and enteral)
  • Structural gastrointestinal disease
  • Any chronic health condition which already requires a restricted diet e.g. diabetes mellitus
  • Functional vomiting disorder with associated weight loss
  • Multiple Type I hypersensitivity reactions to food groups (i.e. anaphylaxis, urticaria, respiratory symptoms or positive RAST tests).
  • Previous or current severe mental health disorder (e.g. severe depression with suicidal ideation)
  • Previous or current eating disorder
  • Positive screen for avoidant restrictive food intake disorder (ARFID)

Treatment and study plan

Dietician advice

Behavioral

Personalised dietetic advice

Primary outcomes

  1. Number of patients

    Time frame: 3 months

    Number of patients who adhere to dietary recommendations based on acceptability of intervention and ease of delivery.

Secondary outcomes

  1. United Kingdom Diet Quality Index as calculated by the Scottish Collaborative Group Food Frequency Questionnaire (SCG FFQ)

    Time frame: 3 months

    170- item semi-quantitative questionnaire, designed to assess the habitual diet of medium to large sized populations during the previous 3 months (higher score means better diet quality)

  2. Gastrointestinal Symptom Rating Scale (GSRS)

    Time frame: 3 months

    13-item questionnaire assessing gastrointestinal symptoms across five domains (pain, bloating, constipation, diarrhoea and satiety) over a period of one week. (min:0 max: 7, higher score means worse symptoms)

  3. Hospital Anxiety and Depression Scale (HADS)

    Time frame: 3 months

    14-item scale assessing symptoms of either anxiety or depression (min: 0 max: 21, higher score means worse anxiety or depression)

  4. Visceral Sensitivity Index (VSI)

    Time frame: 3 months

    15-item measurement of gastrointestinal-specific anxiety (min: 0 max: 75, higher score means worse gastrointestinal specific anxiety)

  5. Patient Health Questionnaire-15 (PHQ-15)

    Time frame: 3 months

    15-item questionnaire to assess the domain of somatic symptoms (min: 0 max: 30, higher score means worse somatic symptoms)

  6. Composite Autonomic Symptom Score (COMPASS-31)

    Time frame: 3 months

    31-item score to assess for symptoms of autonomic nervous system disturbance (min: 0 max 100, higher score means worse autonomic symptoms)

  7. Short Form 6D version 2 (SF-6Dv2)

    Time frame: 3 months

    6-item questionnaire to assess impact of physical symptoms on daily functioning and quality of life (ranges from 1 (full health) to -0.574 (worst health); 0 (death))

  8. Resource Use Questionnaire

    Time frame: 3 months

    16-item questionnaire to assess healthcare and health product utilisation over the preceding 3 months (no minimum / maximum, no score)

Sponsors and collaborators

Lead sponsor

Queen Mary University of London

Other

Collaborators

  • University College, London

Registry information

Official study title

Comprehensive Assessment of Nutrition & Dietary Intervention in Hypermobile Ehlers Danlos Syndrome (hEDS/HSD): a Personalised Approach: Phase 2 & 3

Acronym: CANDI-hEDS2

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 8, 2021
Registry last updated
Aug 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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